Absorbable fastener and applying apparatus

ABSTRACT

A surgical fastener apparatus, for securing a surgical mesh material to body tissue including a pair of anchors each having retaining means formed on an outer surface thereof, and a suture tether interconnecting the pair of anchors to one another. The pair of anchors having a substantially cylindrical body having a conically tapered distal end and a planar proximal end. The retaining means includes a series of semi-circular angled projections having a planar proximal surface and a tapered distal end, wherein a center of each of the angled projections is spaced a distance from a longitudinal central axis of the body portion. The surgical fastener is made from a bioabsorbable material which reabsorbs into said body tissue at an appropriate rate, such as for example, polyglycolic acid and polylactic acid.

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. provisionalapplication Serial No. 60/242,647 filed Oct. 23, 2000, the entirecontents of which is hereby incorporated by reference.

BACKGROUND

[0002] 1. Technical Field

[0003] The present disclosure relates to a surgical fastener and to anapparatus for applying the surgical fastener as well as to a procedurefor fastening objects to body tissue. More particularly, the presentdisclosure relates to an absorbable surgical fastener and apparatus forapplying the absorbable fastener. In addition, the present disclosurerelates to procedures for fastening an object to tissue and toprocedures that require fastening of tissue together.

[0004] 2. Background of Related Art

[0005] Fastening objects to body tissues is a commonly required task inmany different surgical applications. One illustrative example of suchan application is in hernia repair procedures wherein a reinforcingsynthetic mesh material is attached to the tissue. A hernia is a generalterm referring to a protrusion of tissue through a wall of a cavity inwhich the tissue is normally contained, also called rupture. An inguinalhernia is a condition in which a loop of intestine enters the inguinalcanal (i.e., a tubular passage through the lower layers of the abdominalwall). A direct inguinal hernia creates a bulge in the groin area, andan indirect hernia descends into the scrotum. In men, a hernia candevelop at the point where the spermatic cord passes out of the abdomeninto the scrotum. An inguinal hernia is a condition in males whichoccurs in approximately 2% of the male population. Often, an inguinalhernia can be pushed back into the abdominal cavity. However, if theinguinal hernia cannot be forced back through the abdominal wall, theherniated bowel may become trapped in the inguinal ring and/orstrangulated. If the flow of blood is restricted (strangulated hernia)or the intestine is blocked (obstructed), emergency surgery isnecessary. Without treatment, the strangulated loop of intestine dies asa result of a lack of blood to the loop of intestine.

[0006] In order to treat the inguinal hernia, surgery is often requiredto reposition the loop of intestine and secure the weakened muscles inthe abdomen. There are two primarily practiced open surgical proceduresfor hernia repair which procedures use reinforcing synthetic mesh. Oneprocedure is the Lichentstein anterior repair method and the other isthe Stoppa preperitoneal repair method. Modifications of theseprocedures exist, as do additional open surgical procedures that do notrequire the placement of reinforcing mesh over the hernia defect.

[0007] The Lichtenstein repair method is a “tension-free hernioplasty”based on two important facts, namely, inguinal hernias are caused by ametabolic disorder, which leads to a progressive destruction of thefibroconnective tissue of the groin, making the tissue unsuitable foruse in hernia repair and the fact that traditional tissue repairs areassociated with undue tension at the suture line, which leads to morepostoperative pain, longer recovery time, and a higher rate of.

[0008] The Lichtenstein repair method includes the following steps.First, a transverse incision is made within a Langer's line, beginningfrom the pubic tubercle. The external oblique aponeurosis is opened andthe spermatic cord with its cremasteric covering, external spermaticvessels, and the genital nerve are freed from the inguinal floor andlifted with a Penrose drain. The spermatic cord is then dissected freefrom the pubic bone area medial to the pubic tubercle in order to makeroom for extending the mesh beyond the pubic tubercle.

[0009] Next, the external oblique aponeurosis is dissected from theunderlying internal oblique muscle and aponeurosis high enough to makeroom for a prosthesis. The sac is then dissected from the cord beyondits neck and inverted into the properitoneal space without ligation orexcision. The proximal end is closed, dissected away from the cordstructures, and inverted into the preperitoneal space. The medial sideof the mesh is then shaped to the patient's anatomy. The first anchoringsuture of the mesh fixes the mesh to the anterior rectus sheath where itinserts into the pubic bone. The lower edge of the mesh is sutured tothe inguinal ligament using the same suture in a continuous fashion andends at the lateral border of the internal ring. A slit is next made onthe lateral end of the mesh, creating 2 tails. The upper tail is thenpassed under the cord and pulled toward the head of the patient, placingthe spermatic cord in between the 2 tails. The upper tail is thencrossed over the lower one and held with a pair of hemostats. The tailsare later sutured together and tucked under the external obliqueaponeurosis.

[0010] The Stoppa method of hernia repair places a single sheet ofprosthetic material (i.e., surgical mesh) between the peritoneum and themusculopectineal orifice. The surgical mesh is then anchored to Cooper'sligaments using nonabsorbable sutures. The Stoppa hernia repair methodis further described in the attached article in Appendix A, the entirecontents of which are hereby incorporated by reference.

[0011] Yet another hernia repair method, known as TransAbdominalPrePeritoneal (TAPP) Laparoscopic Hernia repair method, generallyincludes the following steps. A pneumoperitoneum is created in theabdomen and an intra-abdominal pressure is maintained. The repair isthen initiated. A laparoscope then inserted and is pointed toward theafflicted inguinal canal. The peritoneal defect or hernia is identified.A peritoneal incision is made, which incision is extended from thelateral aspect of the inguinal region to the lateral umbilical ligament.The Cooper's ligament is then exposed as well as the inferior epigastricvessels and the spermatic Cord. The indirect inguinal hernia sac is thendissected carefully from the spermatic cord. A surgical mesh is theninserted into the intra-abdominal cavity and deployed over the inguinalregion. There are three methods to place and secure the mesh over theinguinal region. The mesh is then secured in place with a surgicalstapler. It is first stapled on to Cooper's ligament followed by placingseveral staples perpendicular to the ligament followed by a row morelateral and parallel to Cooper's Ligament. The graft is also anchoredaround the inferior epigastric vessels and lateral to them. If the meshis wrapped around the spermatic cord, both limbs of the mesh are stapledclosed. The peritoneum is then closed using additional staples andhomeostasis is checked.

[0012] Yet another hernia repair method is known as TotalExtraPeritoneal (TEP) Laparoscopic Hernia repair method. This method isidentical to the TAPP repair method, however, it entirely takes place inthe preperitoneal space. The TEP method includes the following steps.Unlike the TAPP repair method, no pneumoperitoneum is created in the TEPrepair method. Instead, a small incision is made below the umbilicus(midline) and the midline exposed. An incision is made slightly lateralto the midline aponevrosis and the anterior and posterior rectus musclesheaths are exposed. The anatomy must first be clearly identified.Cooper's ligament should be first visualized as well as the inferiorepigastric vessels. The indirect hernia sac should be bluntly pulledaway from the spermatic cord and the inguinal canal. The hernia sacshould then be dissected as medially as possible to allow a surgicalmesh to cover the entire inguinal region. The mesh is then inserted andstapled into place as in the TAPP repair method. With the repaircompleted the small incisions can be closed.

[0013] The two most common of these methods are the TotalExtraPeritoneal (TEP) repair method and the TransAbdominal PrePeritoneal(TAPP) repair method. As discussed above, each of these methods utilizesa reinforcing synthetic mesh that must be fixed to the tissue to preventearly migration of the mesh away from the hernia site. However, the meshmust be anchored into place at first in order to prevent its movementfrom the hernia repair sight. Only after 7-10 days, does the mesh havesufficient tissue in-growth to prevent its motion away from the herniarepair site.

[0014] Each of the above disclosed procedures utilizes titanium staplesto retain the mesh in place. These staples become permanent residents inthe body cavity. A disadvantage of permanent metal staples is thepossibility of the formation of excessive scar tissue (adhesions) whichcan in turn cause further patient complications and hinder futuresurgical procedures. In addition, these permanent staples may beassociated with increased long-term discomfort to the patient as aresult of the hernia repair procedure.

[0015] Accordingly, a need exists for an improved surgical fastener andapplying apparatus as well as for methods in securing objects to bodytissue, for example such as in attaching a mesh material for asufficient time to a hernia repair site until sufficient tissuein-growth occurs to retain the mesh in place.

SUMMARY

[0016] It is an object of the present disclosure to provide anabsorbable surgical fastener apparatus and methods in which the amountof foreign material in the patients body is reduced, thereby minimizingadhesion formation and reducing fastener-associated long-term discomfortto the patient.

[0017] It is another object of the present disclosure to provide anabsorbable surgical fastener and method which is easier and faster touse than traditional suturing techniques in open procedures. Further,the relatively high firing force that can be applied to the absorbablefasteners of the present disclosure facilitate more reliable penetrationof tougher tissue materials, such as for example, Cooper's ligament.

[0018] It is yet another object of the present disclosure to provide anabsorbable surgical fastener which is radiolucent and provides greaterpeace of mind for the patient.

[0019] It is still a further object of the present disclosure to providean absorbable surgical fastener apparatus having a suture tetherdisposed between anchoring barbs. The tether provides the advantage ofholding the mesh in place loosely thus minimizing the tension in thesurrounding tissue and reducing fastener pull-out occurrences.

[0020] It is another object of the present disclosure to provide asurgical fastener apparatus which is dimensioned to not penetrate theabdominal wall of the patient and which is provided with a series ofbarbs having a relatively larger surface than standard fastener barbs tothereby better retain the fastener in soft tissue.

[0021] The presently disclosed surgical fastener apparatus and methodserve the function of previously used staples to secure objects to bodytissue as performed in previous methods, for example, mesh being fixedto specific anatomic landmarks surrounding the hernia repair, orattaching mesh to tissue, or attaching tissue to tissue or attachingtissue to ligaments. However, the presently disclosed absorbablefastener apparatus and method have the uniquely advantageous featurethat the absorbable fasteners are utilized to attach the mesh to thetissue for a sufficient time to allow tissue in-growth to occur on themesh material. In this manner, the absorbable fasteners help preventearly mesh migration and then after sufficient tissue in-growth areabsorbed in the body.

[0022] A surgical fastener apparatus is provided for securing a surgicalmesh material to body tissue, in which the apparatus includes a pair ofanchors each having retaining means formed on an outer surface thereofand a suture tether interconnecting said pair of anchors to one another.The fastener apparatus is preferably made from a bioabsorbable materialand is dimensioned such that the apparatus will only be partiallyabsorbed over a period of 2 to 3 weeks after implantation and will becompletely absorbed into the body at any time thereafter.

[0023] In an alternate embodiment, the surgical fastener apparatusincludes a conical body portion having a pointed distal tip and anenlarged proximal head. The conical body portion being provided with ahelical thread commencing at or near the distal tip and terminatingpreferably at a distance spaced from the enlarged proximal head.

[0024] In addition, a hernial repair method utilizing the fasteners inaccordance with the present disclosure is provided in which a surgicalmesh is secured in place over the hernia repair site by imbedding thesurgical fasteners in to body tissue through the surgical mesh.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Various embodiments of the presently disclosed surgical fastenerand methods will be described herein with reference to the accompanyingdrawing figures wherein:

[0026]FIG. 1 is an enlarged perspective view of one embodiment of anabsorbable surgical fastener apparatus constructed in accordance withthe present disclosure;

[0027]FIG. 2 is a side view of a barb portion of the absorbable surgicalfastener apparatus of FIG. 1;

[0028]FIG. 3 is an enlarged perspective view of an alternativeembodiment of an absorbable surgical fastener in accordance with thepresent disclosure;

[0029]FIG. 4 is an end view of the surgical fastener of FIG. 3;

[0030]FIG. 5 is an enlarged perspective view of an absorbable surgicalfastener apparatus including a pair of fasteners as shown in FIG. 3;

[0031]FIG. 6 is a cross-sectional view of the absorbable fastener shownin FIG. 5, taken along the longitudinal axis;

[0032]FIG. 7 is an illustration of a sequential step in one embodimentof attaching an object to body tissue using the presently disclosedabsorbable surgical fasteners;

[0033]FIG. 8 is a further sequential step according to the methodembodiment of FIG. 7;

[0034]FIG. 9 is a still further sequential step of the method of FIG. 7;

[0035]FIG. 10 is another sequential step of the method of FIG. 7; and

[0036]FIG. 11 is another illustration of a step of the method embodimentof FIG. 7.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0037] Preferred embodiments of the presently disclosed absorbablesurgical fastener apparatus and method of applying same will now bedescribed in detail with reference to the drawing figures wherein likereference numerals identify similar or identical structural elements.

[0038] The presently disclosed absorbable surgical fastener apparatusand method is shown and described herein in connection with open andlaparoscopic inguinal, femoral and ventral hernia repairs. Although notdescribed in detail herein, the absorbable fastener can also be appliedto other procedures which require that objects be attached to bodytissue.

[0039] Referring initially to FIGS. 1 and 2, an absorbable surgicalfastener apparatus for connecting objects to body tissue, such asabsorbable fastener 10 includes dual fastener anchors 12 and 14 securedto one another by a suture tether 16 extending therebetween. Each anchor12 and 14 has a substantially cylindrical body portion 18 having aconically tapered distal end 20 and a substantially planar proximal endsurface 22. Anchors 12 and 14 are preferably provided with conicallyshaped distal ends 20 for easier penetration of anchors 12 and 14 intohard tissues, such as, for example, Cooper's ligament. While a generallyconical distal end has been disclosed, it is envisioned that othershaped ends (e.g., pyramid, and the like) can be provided. Each anchor12 and 14 is provided with a pair of opposed flattened side surfaces 22extending longitudinally along the length thereof.

[0040] Anchors 12 and 14 are provided with barbs 12 a,12 b,12 c, and 14a,14 b,14 c respectively to inhibit fastener pull-out occurrences ineither hard or soft tissue. Each barb is semi-circular having a planarproximal surface 24 which is orthogonal to a central longitudinal axis“A” of each anchor 12 and 14, and a tapered lower surface 26.Preferably, barbs 12 a-12 c and 14 a-14 c share a common central axis“B”, however, it is envisioned that each respective barb can have adifferent center as compared to other barbs on the anchor. Preferably,central axis “B” is spaced a distance “X” from longitudinal axis “A”. Inthis manner, the center of barbs 12 a-12 c and 14 a-14 c can bepositioned to reveal a greater amount of planar proximal surface 24 inorder to provide an anchor with predetermined anchoring and securingcharacteristics for body tissue without compromising the strength ofbody portion 18 of each anchor 12 and 14. For example, if greaterretaining strength is desired, distance “X” between central axis “B” andlongitudinal axis “A” is increased thereby forming a bard with a largerplanar proximal surface 24. In the case of securing a fastener to softtissue, as is the case in hernia repair, a fastener having a largerprojecting barb is desired in order to better anchor the fastener intothe soft tissue of the patient.

[0041] While each barb 12 a-12 c and 14 a-14 c is orthogonal tolongitudinal axis “A” of each anchor 12 and 14 respectively, it isenvisioned that each barb can be angled relative to longitudinal axis“A” such that barbs 12 a, 12 b and 12 c form a partial thread aroundbody portion 18 of each anchor 12 and 14. In this manner, as each anchor12 and 14 is pressed into body tissue, each anchor 12 and 14 will rotateinto the body tissue.

[0042] Although the embodiment of FIGS. 1 and 2 illustrate barbs formedpartially around the circumference of anchors 12 and 14, multiple barbconfigurations can be utilized and are within the scope of the presentdisclosure. For example, in addition to the illustrated configuration,single barb, circumferential barb (i.e., barbs encircling the entireanchor), sharp barbs, dull barbs, multiple barbs, and variousgeometrically shaped barbs may be utilized.

[0043] While a planar proximal end 20 has been shown, it is envisionedthat each anchor 12 and 14 can be provided with a notch or detent (notshown) formed in the proximal end thereof. In this manner, when a seriesof absorbable fasteners 10 are joined together, the tapered distal ends18 are received in the detents to thereby maintain the absorbablefasteners 10 and anchors 12 and 14 longitudinally aligned with oneanother.

[0044] Absorbable fasteners 10 are preferably made of medical gradeabsorbable materials, for example, Polyglycolic Acid (PGA) andPolylactic Acid (PLA). A critical feature of the presently disclosedabsorbable fastener is that the absorbable fastener provide sufficientstrength to retain a mesh material in place for a desired period oftime. For example, in the case of applying a hernia repair meshmaterial, it is recommended that absorbable fasteners 10 remain in placeretaining the mesh material for approximately 2-3 weeks and be absorbedinto the body tissue anytime after that.

[0045] It is preferred that absorbable fasteners 10 are approximately 3mm long, from the tip of distal end 18 to proximal end 20, byapproximately 1.5 mm in diameter. Other suitably configured anddimensioned fasteners may also be utilized depending on the particularapplication. It is also preferred that absorbable fasteners 10 areconfigured and dimensioned to avoid penetrating too far into the tissue.An example of a similar fastener structure and an instrument forapplying such fasteners are disclosed in U.S. Pat. No. 5,997,552(hereinafter “the '552 patent”), issued to Person et al. and entitledMeniscle Fastener Applying Device, the entire contents of which arehereby incorporated by reference. Unlike the fastener in the '552patent, the barbs of fastener 10 according to the present disclosurehave a center “B” which is spaced a distance “X” from the longitudinalaxis “A” of the anchor as opposed to the body of the anchor being cutaway to reveal a barb in the '552 patent. In this manner, a barb havinga larger height is achieved without altering the dimensions of the bodyportion, which larger height more firmly secures the anchor of fastener10 into body tissue as compared to the fastener disclosed in the '552patent.

[0046] Unlike the applicator instrument for placing absorbable fasteners10 disclosed in U.S. Pat. No. 5,997,552, previously incorporated byreference herein, the applicator according to the present disclosure ispreferably adapted to fire 20 to 30 fasteners per instrument for use ineither open and/or laparoscopic procedures. It is envisioned that theapplicator instrument be either entirely disposable after use or beprovided with a replaceable cartridge of fasteners which can be coupledto the end of a reusable applicator and replaced within a givenprocedure while the handle of such an applicator would still bedisposable but would be reusable within a single procedure. While analternate applier may be used, the fastener applier disclosed in the'552 reference can be used to apply the surgical fasteners disclosedherein.

[0047] By way of example, the general procedure of applying a meshmaterial during a hernia repair procedure, is to first create an accessto the location of the hernia (i.e., incision and dissection) therebyexposing the hernia; then place a prosthetic mesh over the herniadefect; next fasten the mesh to the surrounding tissue by firing aplurality of absorbable fasteners 10 through the mesh and into tissue tothereby secure the mesh into place; and finally close the access wound.

[0048] Turning now to FIGS. 3-5, an alternative embodiment of a surgicalfastener in accordance with the present disclosure in shown generally as200. As seen in FIGS. 3 and 4, fastener 200 includes a substantiallyconical body portion 202 depending from a circular head portion 204.Conical body portion 202 includes a helical thread 206 commencing at apointed distal tip 208 of body portion 202 and terminating at a distancespaced from head portion 204. As the helical thread 206 advances fromdistal tip .206 toward head portion 204, the radial projection of thehelical thread 206 from the body portion 202 increases. While thehelical thread 206 is disclosed as commencing at the distal tip 208, itis envisioned that the helical thread 206 can commence at a distancespaced from the distal tip 208. In addition, head portion 204 can beprovided with a recess or notch (not shown) formed in the center of theproximal surface thereof. The recess being configured to receive thedistal tip 208 of an adjacent fastener 200 therein. In this manner, aseries of fasteners 200 can be aligned in a tip-to-tail fashion with oneanother and share a common axis.

[0049] In use, fastener 200 is pressed into body tissue “T”, throughsurgical mesh “M”, until the entire body portion 202 of fastener 200 haspassed through mesh “M” and has been buried in tissue “T”. Head portion204 ensures that fastener 200 does not completely pass through mesh “M”thereby ensuring that mesh “M” is in contact with tissue “T”. Fastener200 includes an arcuate tooth 210 projecting radially outwardly from theproximal end of helical thread 206 and oriented such that the curve ofthe arcuate tooth 210 is oriented to inhibit a rotation of fastener 200which would remove fastener 200 from body tissue “T”.

[0050] Turning now to FIG. 5, a surgical fastener apparatus according tothe present disclosure is shown generally as 300. Similar to fastener200, surgical fastener apparatus 300 includes a pair of substantiallyconical anchors 302 each having a helical thread 304 commencing at adistal tip 306 of each anchor 302 and terminating at a proximal endsurface 308 of each anchor 302. Once again, the radial projection of thehelical thread 304 on anchor 302 increases as the helical thread 304advances from the distal tip 306 to the proximal end of the anchor 302.While the helical thread 304 is disclosed as commencing the distal tip306, it is envisioned that the helical thread 304 can commence at adistance spaced from the distal tip 306 just as well. Anchors 302 areconnected to one another by a suture tether 310 extending therebetween.As seen in FIG. 5, the orientation of helical thread 304 on each anchor302 is in the same direction. In this manner, as anchors 302 are beingimbedded into body tissue and commence rotating in the direction ofhelical thread 304, suture tether 310 on each anchor 302 will rotate inthe same direction and not become tightened. The proximal end of eachhelical thread is provided with an arcuate tooth 312, which arcuatetooth 312 is oriented such that after anchors 302 have been completelyimbedded into the body tissue the tooth 312 will dig into the bodytissue if the anchor is rotated in a direction which would remove theanchor from the body tissue. Similar to fastener 10, surgical fastenerapparatus 300 can be provided with a detent or recess 314 (see FIG. 6)formed in the proximal end surface thereof. In this manner, a series offasteners 300 can be aligned in tip-to-tail fashion with one another ina fastener applier so that fasteners 300 share a common axis.

[0051] As seen in FIG. 6, helical thread 304 is made up of a distalsurface 316 and a proximal surface 318 joined together to form a sharpedge 320. In addition, suture tether 310 is fixedly retained withinanchors 302, however, it is envisioned that suture tether 310 can berotatably mounted to proximal surface 308.

[0052] Fasteners 200 and 300 are also preferably made of medical gradeabsorbable materials, for example, Polyglycolic Acid (PGA) andPolylactic Acid (PLA). A critical feature of the presently disclosedabsorbable fastener is that the absorbable fastener provide sufficientstrength to retain a mesh material in place for a desired period oftime. For example, in the case of applying a hernia repair meshmaterial, it is recommended that absorbable fasteners 200 or 300 remainin place retaining the mesh material for approximately 2-3 weeks and beabsorbed into the body. tissue anytime after that. In addition, it ispreferred that absorbable fastener 200 and that each anchor of fastenerapparatus 300 are approximately 3 mm long, from the tip of distal end tothe proximal end, and wherein the proximal end is approximately 1.5 mmin diameter. It is preferred that fastener 200 and fastener apparatus300 are configured and dimensioned to avoid penetrating too far into thebody tissue.

[0053] Fasteners 200 and 300 can be imbedded into body tissue by eitherpressing the fastener in to the tissue and allowing the thread on thefastener to automatically twist the fastener into the tissue, byproviding a twisting applier which turns the fastener and thus thehelical threads draw the fastener into the body tissue or by acombination of pressing and twisting.

[0054] By way of example only, and not to be considered limiting in anyway, with reference to FIGS. 7-11, a Lichtenstein repair method will nowbe described as performed using any of the absorbable surgical fastenersin accordance with the present disclosure. First, a 5 cm to 6 cmtransverse incision is made within a Langer's line, beginning from thepubic tubercle. The external oblique aponeurosis is opened. As shown inFIG. 7, the spermatic cord with its cremasteric covering, externalspermatic vessels, and the genital nerve are freed from the inguinalfloor and lifted with a Penrose drain. The spermatic cord is dissectedfree from the pubic bone area for approximately 2 cm medial to the pubictubercle in order to make room for extending a prosthetic mesh beyondthe pubic tubercle. The external oblique aponeurosis is dissected fromthe underlying internal oblique muscle and aponeurosis high enough tomake room for a prosthesis that is 6 cm to 7 cm in height. The sac isthen dissected from the cord beyond its neck and inverted into theproperitoneal space without ligation or excision.

[0055] Referring to FIG. 8, a medial side of the mesh, is shaped to thepatient's anatomy. A first absorbable fastener 10, 200 or 300 is appliedto the mesh to fix the mesh to the anterior rectus sheath where itinserts into the pubic bone. The absorbable fastener is placedapproximately 2 cm medial to the pubic tubercle in order to be sure thatthe area is covered by the mesh. Additional absorbable fasteners 10, 200or 300 are placed therearound and end at the lateral border of theinternal ring. The lower edge of the mesh is then anchored to theinguinal ligament using the same fasteners 10, 200 or 300 around thesurgical mesh and ending at the lateral border of the internal ring.

[0056] According to one method of the present disclosure, the absorbablefastener is secured into place by firing the fastener into the bodytissue such that a first anchor of the surgical fastener penetratesthrough the surgical mesh and into the body tissue and such that asecond anchor of the surgical fastener is implanted directly into thebody tissue. In this manner, the suture tether of the fastener apparatusextends partially across the surgical mesh and partially across bodytissue. In an alternative method, an absorbable fastener in accordancewith the present disclosure, can be secured into place such that bothanchors are imbedded into the body tissue and pass through the surgicalmesh. If fastener 200 is used in the method, fasteners 200 are anchoredinto the body tissue solely through the mesh.

[0057] A slit is then made on the lateral end of the mesh, as seen inFIG. 9, creating 2 tails—⅔ above and ⅓ below. The upper tail is thenpassed under the cord and pulled toward the head of the patient, placingthe spermatic cord in between the 2 tails. The upper tail is thencrossed over the lower one and held with a pair of hemostat, as seen inFIG. 10. The tails are later sutured together and tucked under theexternal oblique aponeurosis, leaving 5 cm to 6 cm of mesh lateral tothe internal ring.

[0058] While the upper edge of the mesh is fixed in place, care is takento keep the mesh slightly relaxed. This laxity produces a dome-likeripple in the mesh to compensate for increased intra-abdominal pressurewhen the patient stands up from his or her recumbent position during theoperation. If the mesh is kept completely flat, it becomes subject totension when the patient stands up. This pulling effect on the mesh andthe tissue, is illustrated when the mesh is kept flat as shown in FIG.11. The use of a surgical fastener in accordance with the presentdisclosure effectively eliminates the tension of the surgical mesh theanchors of the surgical fastener are relatively movable with respect toone another. In other words, one anchor is able to move with respect tothe other anchor if needed as the patients body tissue shifts. In sodoing, the tension on the mesh is reduced since the suture tetherprovides the mesh with some room to move since the individual anchorsare moveable with respect to one another.

[0059] A Total ExtraPeritoneal Laparoscopic Hernia repair usingfasteners 10 or 300, in accordance with the present disclosure, will nowbe described. First, a skin incision is created and the fascia isincised. A balloon type distractor is then placed therein and distendedin order to create an operative extraperitoneal space. Umbilical trocarsand secondary trocars are then inserted into the extraperitoneal spaceand the space explored. The medial and lateral structures are thendissected and the spermatic chord identified. A surgical mesh is thencut to the desired size and shape such that a slit is provided in orderto wrap the mesh on either side of the spermatic chord. The mesh is thenlaterally fixed in place using surgical fasteners 10, 200 or 300 inorder to anchor the mesh to the tranversus arch and the iliopubic tract.This step is repeated for the opposite side. The mesh is then mediallyfixed in place using additional fasteners 10, 200 or 300 to thetransversus arch and to Cooper's ligament or in the alternative, fix themesh to the medial iliopubic tract. Finally, the incision is closed.

[0060] It is envisioned that fasteners 10, 200 or 300 can be used in aTAPP repair method to replace suturing of the mesh both laterally andmedially. In the TAPP repair method, fasteners 10, 200 or 300 are usedto secure the mesh in to place by penetrating the mesh and beinganchored into the body tissue.

[0061] While each of the above described fasteners have been describedas being used in connection with hernial repair surgery, it isenvisioned that fasteners having a similar structure can be used insurgical procedures for fastening items to bone or cartilage. In suchsurgical procedures, the surgical fasteners can be made from surgicalgrade stainless steel, titanium or any other surgical grade materialhaving sufficient strength to penetrate bone.

[0062] It will be understood that various modifications may be made tothe embodiments of the presently disclosed surgical absorbable fastenerapparatus and methods disclosed herein. Therefore, the above descriptionshould not be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the present disclosure.

We claim:
 1. A surgical fastener apparatus for securing a surgical meshmaterial to body tissue, comprising: a pair of substantially cylindricalanchors, wherein each anchor is provided with a conically tapered distalend and a substantially planar proximal end, and wherein each anchormember is further provided with a series of semi-circular angledprojections having a proximal surface and a tapered distal end andwherein a center of said series of angled projections is spaced adistance from a longitudinal central axis of said anchors; and a tetherinterconnecting said proximal ends of said pair of anchors.
 2. Thesurgical fastener according to claim 1, wherein said pair of anchors aremade from a bioabsorbable material.
 3. The surgical fastener accordingto claim 2, wherein said bioabsorbable material is selected from amaterial which reabsorbs into said body tissue at an appropriate rate.4. The surgical fastener according to claim 2, where said bioabsorbablematerial is selected from the group consisting of polyglycolic acid andpolylactic acid.
 5. The surgical fastener according to claim 1, wheresaid pair of anchors and said tether are dimensioned to be partiallyabsorbed into said body tissue for at least a period of approximately 2to 3 weeks immediately after implanting and are fully absorbed into saidbody tissue at any time thereafter.
 6. The surgical fastener accordingto claim 1, wherein said pair of anchors have a length of approximately3 mm from a distal tip of said tapered distal end to said planarproximal end.
 7. The surgical fastener according to claim 6, whereinsaid pair of anchors have a diameter of approximately 1.5 mm.
 8. Thesurgical fastener according to claim 1, wherein said tether is made froma bioabsorbable material.
 9. The surgical fastener according to claim 8,wherein said bioabsorbable material is selected from the groupconsisting of polyglycolic acid and polylactic acid.
 10. The surgicalfastener according to claim 1, wherein said tether is nonrigid.
 11. Asurgical fastener apparatus, for securing a surgical mesh material tobody tissue, comprising: a pair of anchors each having retaining meansformed on an outer surface thereof; and a suture tether interconnectingsaid pair of anchors to one another.
 12. The surgical fastener apparatusaccording to claim 11, wherein each of said pair of anchors include asubstantially cylindrical body portion having a conically tapered distalend and a substantially planar proximal end.
 13. The surgical fastenerapparatus according to claim 12, wherein said retaining means includes aseries of semi-circular angled projections having a substantially planarproximal surface and a tapered distal end, wherein a center of each ofsaid angled projections is spaced a distance from. a longitudinalcentral axis of said body portion.
 14. The surgical fastener apparatusaccording to claim 13, wherein said suture tether is operatively coupledto said planar surface of each of said pair of anchors.
 15. The surgicalfastener apparatus according to claim 11, wherein each of said pair ofanchors includes a conical body portion having a helical threadextending therearound.
 16. The surgical fastener apparatus according toclaim 15, wherein said helical thread commences from a distal tip ofeach of said anchors and terminates at a proximal end of each of saidanchors.
 17. The surgical fastener apparatus according to claim 16,wherein said suture tether is operatively coupled to said proximal endof each of said anchors.
 18. The surgical fastener apparatus accordingto claim 15, wherein said helical thread increases in a radial directionas said helical thread progresses from said distal end to said proximalend.
 19. The surgical fastener apparatus according to claim 11, whereinsaid pair of anchors are made from a bioabsorbable material.
 20. Thesurgical fastener according to claim 19, wherein said bioabsorbablematerial is selected from a material which reabsorbs into said bodytissue at an appropriate rate.
 21. The surgical fastener according toclaim 19, where said bioabsorbable material is selected from the groupconsisting of polyglycolic acid and polylactic acid. 22 The surgicalfastener according to claim 11, where said pair of anchors and saidtether are dimensioned to be partially absorbed into said body tissuefor at least a period of approximately 2 to 3 weeks immediately afterimplanting and are fully absorbed into said body tissue at any timethereafter.
 23. The surgical fastener according to claim 11, whereinsaid pair of anchors have a length of approximately 3 mm from a distaltip of said tapered distal end to said planar proximal end.
 24. Thesurgical fastener according to claim 23, wherein said pair of anchorshave a diameter of approximately 1.5 mm.
 25. The surgical fasteneraccording to claim 11, wherein said tether is made from a bioabsorbablematerial.
 26. The surgical fastener according to claim 25, wherein saidbioabsorbable material is selected from the group consisting ofpolyglycolic acid and polylactic acid.
 27. The surgical fasteneraccording to claim 11, wherein said tether is nonrigid.
 28. A surgicalfastener for securing surgical mesh material to body tissue, comprising:a conical body portion having a pointed distal tip and an enlargedproximal head; and a helical thread extending radially from said conicalbody portion.
 29. The surgical fastener according to claim 28, whereinsaid helical thread commences at said distal tip and terminates at adistance spaced from said distal tip.
 30. The surgical fasteneraccording to claim 29, wherein said helical thread increases in a radialdirection as said helical thread progresses from said distal end to saidproximal end.
 31. The surgical fastener according to claim 30, whereinsaid fastener is made from a bioabsorbable material.
 32. The surgicalfastener according to claim 31, wherein said bioabsorbable material isselected from the group consisting of polyglycolic acid and polylacticacid.
 33. The surgical fastener according to claim 30, wherein saidfastener is dimensioned to be partially absorbed into said body tissuefor at least a period of 2 to 3 weeks immediately after implanting andis fully absorbed into said body tissue at any time thereafter.
 34. Thesurgical fastener according to claim 33, wherein said fastener has alength of approximately 3 mm from said distal tip to said head.
 35. Amethod for applying a surgical mesh material to a hernial repair siteduring a hernia repair procedure, comprising the steps of: creating anaccess to the location of said hernial repair site to expose saidhernial repair site; placing a surgical mesh into position over saidhernial repair site, wherein said mesh covers said hernial repair siteand extends over surrounding body tissue; providing an absorbablesurgical fastener having a pair of anchors with each anchor havingretaining means formed on an outer surface thereof, and a suture tetherinterconnecting said pair of anchors to one another; fastening saidsurgical mesh to said hernial repair site by imbedding a plurality ofsaid absorbable surgical fasteners through said surgical mesh and intosaid surrounding body tissue; and closing said access to said hernialrepair site.
 36. The method for fastening a surgical mesh according toclaim 35, wherein said absorbable surgical fasteners are oriented suchthat a first of said pair of anchors is directly imbedded into saidsurrounding body tissue and a second of said pair of anchors is imbeddedinto said body tissue through said surgical mesh.
 37. The method forfastening a surgical mesh according to claim 35, wherein said absorbablesurgical fasteners are oriented such that said pair of anchors areimbedded into said body tissue through said surgical mesh.
 38. Themethod for fastening a surgical mesh according to claim 35, wherein eachof said pair of anchors include a substantially cylindrical body portionhaving a conically tapered distal end and a substantially planarproximal end.
 39. The method for fastening a surgical mesh according toclaim 38, wherein said retaining means includes a series ofsemi-circular angled projections having a substantially planar proximalsurface and a tapered distal end, wherein a center of each of saidangled projections is spaced a distance from a longitudinal central axisof said body portion.
 40. The method for fastening a surgical meshaccording to claim 39, wherein said suture tether is operatively coupledto said planar surface of each of said pair of anchors.
 41. The methodfor fastening a surgical mesh according to claim 35, wherein each ofsaid pair of anchors includes a conical body portion having a helicalthread extending therearound.
 42. The method for fastening a surgicalmesh according to claim 41, wherein said helical thread commences from adistal tip of each of said anchors and terminates at a proximal end ofeach of said anchors.
 43. The method for fastening a surgical meshaccording to claim 42, wherein said suture tether is operatively coupledto said proximal end of each of said anchors.
 44. The method forfastening a surgical mesh according to claim 41, wherein said helicalthread increases in a radial direction as said helical thread progressesfrom said distal end to said proximal end.
 45. The method for fasteninga surgical mesh according to claim 35, wherein said pair of anchors aremade from a bioabsorbable material.
 46. The method for fastening asurgical mesh according to claim 45, wherein said bioabsorbable materialis selected from a material which reabsorbs into said body tissue at anappropriate rate.
 47. The method for fastening a surgical mesh accordingto claim 45, where said bioabsorbable material is selected from thegroup consisting of polyglycolic acid and polylactic acid.
 48. Themethod for fastening a surgical mesh according to claim 35, where saidpair of anchors and said tether are dimensioned to be partially absorbedinto said body tissue for at least a period of approximately 2 to 3weeks immediately after implanting and are fully absorbed into said bodytissue at any time thereafter.
 49. The method for fastening a surgicalmesh according to claim 35, wherein said pair of anchors have a lengthof approximately 3 mm from a distal tip of said tapered distal end tosaid planar proximal end.
 50. The method for fastening a surgical meshaccording to claim 49, wherein said pair of anchors have a diameter ofapproximately 1.5 mm.
 51. The method for fastening a surgical meshaccording to claim 35, wherein said tether is made from a bioabsorbablematerial.
 52. The method for fastening a surgical mesh according toclaim 51, wherein said bioabsorbable material is selected from the groupconsisting of polyglycolic acid and polylactic acid.
 53. The method forfastening a surgical mesh according to claim 52, wherein said tether isnonrigid.